• Clinical Packaging RFPs Made Easy
    Clinical Packaging RFPs Made Easy

    Managing clinical supplies is hard. Not hard like string theory — more like organizing a family vacation with your adult siblings and all their children. Clinical supplies management sits at the intersection of multiple disciplines, each with its unique perspectives and priorities. Their collective attention may be difficult to hold for something as seemingly trivial as packaging. However, clinical packaging is critical to the success of a program and a company, and an effective request for proposal (RFP) will guide you to the right packaging partner for your journey to product approval.

  • Should You Rotate Disinfectants? Industry Experts Weigh In
    Should You Rotate Disinfectants? Industry Experts Weigh In

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.

  • Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?
    Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products

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Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.

Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production

Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

6 Myths About Biocatalysis Every Manufacturer Should Ignore

By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.

Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

9 Reasons To Consider A Single-Use Fermentor

Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets

Improve Operational Efficiency In Biomanufacturing With Comprehensive Automation Solutions

This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.

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eTMF And The eClinical Universe

How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.

H1N1 Vaccine Program

Seamless teamwork among INC Research/inVentiv Health, sponsor and sites results in multinational studies with zero audit findings.

Process Economy Of Using Cytodex™ Gamma Microcarriers

Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use. The process economy comparison performed in this work was made for the preparation step of Cytodex 1 versus Cytodex 1 Gamma microcarriers. Two scales were included: 100 L pilot and 500 L production scales.

Production Of Antibody Fragments By S. Cerevisiae In Single-Use Fermentor

Advances in single-use bioprocess technology have led to the development of the Thermo Scientific HyPerforma Single-Use Fermentor (SUF), the first specifically designed fermentor of its kind.

More Pharma Outsourcing App Notes & Case Studies


Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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